This invention relates to an absorbent article, particularly a tampon having additives that reduce toxic shock syndrome toxin (TSST-1) production.
Efforts to inhibit the production of toxic shock syndrome toxin (TSST-1) production are described in U.S. Pat. Nos. 5,547,985 and 5,612, 045. However, certain additives, while reducing toxic shock syndrome toxin production, will negatively impact the wearer""s vaginal flora. Therefore, a need exists to provide a tampon having additives that will reduce toxic shock syndrome toxin (TSST-1) production without adversely affecting the normal vaginal flora or, if applied as a bandage, the normal flora at the relevant body site.
This invention relates to an absorbent article, particularly a tampon having additives that reduce toxic shock syndrome toxin (TSST-1) production without adversely affecting a woman wearer""s vaginal flora.
In one preferred embodiment, this invention relates to a tampon that has a combination of at least one oxygen inhibiting agent and at least one surface active agent or humectant selected from a specific group applied thereto. The terms xe2x80x9coxygen inhibiting agentxe2x80x9d or xe2x80x9coxygen inhibitor,xe2x80x9d as used herein refer to: a reducing agent, a free radical scavenger, an antioxidant or some other agent that reduces the amount of oxygen within a tampon. Particularly preferred oxygen inhibiting agents for use in the present invention include: ascorbic acid, vitamin E, N-acetylcysteine, and beta-mercaptoethanol. The surface active agent can comprise surfactants, which include, but are not limited to Tween 20(trademark) (Polysorbate 20). In an alternative preferred embodiment of the present invention, the surface active agent may be replaced by glycerin (glycerol), a humectant. The reducing agent and surface active agent can be applied to: the surface of the absorbent tampon material; the surfaces of the fibers comprising the tampon; to the tampon applicator; or any combination of the foregoing. It is believed that oxygen inhibiting agents and surfactants or humectants interfere with the production of TSST-1 by at least two different mechanisms, thereby enhancing the effectiveness of the combination over that of either class alone.
The present invention also relates to a composition of matter for adding to an absorbent article to reduce toxic shock syndrome toxin (TSST-1) production, and to a method for reducing toxic shock syndrome toxin (TSST-1) production.
This invention relates to an absorbent article, particularly a tampon that has additives that reduce toxic shock syndrome toxin (TSST-1) production without adversely affecting the normal vaginal flora or normal flora elsewhere where other types of absorbent articles may be applied.
There exists in the female body a complex process which maintains the vagina and physiologically related areas in a healthy state. In a female between the age of menarche and menopause, the normal vagina provides an ecosystem for a variety of microorganisms. Bacteria are the predominant type of microorganism present in the vagina. Most women harbor about 109 bacteria per gram of vaginal exudate. The bacterial flora of the vagina is comprised of both facultative and anaerobic bacteria. The more commonly isolated bacteria are Lactobacillus species, Corynebacteria species, Gardnerella vaginalis, Staphyloccus species, Peptococcus species, facultative and anaerobic streptococcal species, and Bateroides species.
Vaginal tampons suitable for use in this invention are usually made of absorbent fibers, including natural and/or synthetic fibers, compressed into a unitary body of a size which may easily be inserted into the vaginal cavity. They are normally made in an elongated cylindrical form in order that they may have a sufficiently large body of material to provide the required absorbing capacity, but may be made in a variety of shapes. The tampon may or may not be compressed, although compressed types are now generally preferred. The tampon may be made of various fiber blends including both absorbent and nonabsorbent fibers, which may or may not, have a suitable cover or wrapper.
The tampon used in the present invention is not limited to any particular configuration. Particularly preferred tampons suitable for use in carrying out the present invention are those manufactured by Tambrands, Inc. of White Plains, N.Y. Patent publications describing tampons suitable for use in carrying out the present invention include: U.S. Pat. No. 5,364,383. Patent publications describing applicators suitable for use in carrying out the present invention are described in U.S. Pat. Nos. 5,346,468 and 5,558,631.
In one preferred embodiment, this invention relates to a tampon that has a combination of at least one oxygen inhibiting agent and at least one surface active agent or humectant selected from a specific group applied thereto. The terms xe2x80x9coxygen inhibiting agentxe2x80x9d or xe2x80x9coxygen inhibitor,xe2x80x9d as used herein refer to: a reducing agent, a free radical scavenger, an antioxidant, or some other agent that displaces oxygen from within the tampon. Antioxidants include natural and synthetic antioxidants. Four common synthetic antioxidants comprise: butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), propyl gallate (PG), and tertiary butylhydroquinone (TBHQ). Natural antioxidants include mixed tocopherols, citric acid, ascorbic acid (vitamin C), ascorbyl palmitate, and erythorbic acid. Other antioxidants include: thiodipropionic acid and salts, sodium and potassium bisulfite, sodium sulfite, and sodium and potassium metabisulfite. Particularly preferred oxygen inhibiting agents for use in the present invention include: ascorbic acid, vitamin E, and N-acetylcysteine. Additionally, materials may be added which exhibit both the properties of oxygen inhibiting agents and surfactants, N-acetylcysteine is a preferred example. The present invention, however, is not limited to the foregoing list of oxygen inhibiting agents.
The term xe2x80x9csurface active agentsxe2x80x9d, as used herein, refers to classes of chemical compounds commonly called surfactants and humectants. Surfactants for the purposes of this invention may include, but are not limited to: TWEEN 20(trademark) (polysorbate 20), TWEEN 40(trademark) (polysorbate 40), TWEEN 60(trademark) (polysorbate 60), TWEEN 80(trademark) (polysorbate 80), PPG-5-laureth-5, PEG-8 stearate, PEG 200 ML, polyethylene glycol, polypropylene glycol, and other glycols, Laureth-3, Laureth-4, sodium laureth sulfate, disodium laureth sulfosuccinate. Tween 20 is a particularly preferred surface active agent for use in this present invention.
In an alternative and preferred embodiment of the present invention, the surface active agent may be replaced by glycerin, a humectant. In still another embodiment, both glycerin and Tween 20 may be used with one or more oxygen inhibiting agent(s).
The compositions of the present invention can be prepared and applied in any suitable form, but are preferably prepared in forms including, without limitation aqueous solutions, lotions, balms, gels, salves, ointments, boluses, suppositories, and the like. The compositions may be applied to the absorbent article using conventional methods for applying an inhibitory agent to the desired absorbent article. For example, depending on their characteristics, the compositions may be sprayed onto the absorbent article, or the absorbent article may be dipped in a liquid bath having the agent therein, and then air dried. The compositions of the present invention are not restricted to use with tampons, but may also be used with other wound salves or dressings, particularly nasal packings and other surgical dressings.
The oxygen inhibiting agent and surface active agent can be applied to the tampon separately, or combined and then applied to the tampon. The oxygen inhibiting agent and the surface active agent (surfactant or humectant) can be applied to: the surface of the absorbent tampon material; the surfaces of the fibers comprising the tampon; to the tampon applicator; or any combination of the foregoing. If the oxygen inhibiting agent and surface active agent are applied to the tampon applicator, these substances should be applied to either a portion of the applicator that will contact the user""s body, a portion of the applicator that will transfer the substances to the tampon, or both.
It has been found that ascorbic acid can reduce toxin production by up to about 40%, but does not inhibit Staphylococcal growth. It has also been found that certain surface active agents, e.g., surfactants, can also reduce toxin production without inhibiting bacterial growth. Without wishing to be bound by any particular theory, it is believed that the surfactants may interfere with TSST-1 production by staphylococci by blocking the transduction of the environmental signal that triggers TSST-1 production across the bacterial cell membrane. Oxygen inhibiting agents, on the other hand, may work by limiting Staphylococcal access to O2 or to some metabolite of O2, of which at least one of those molecular species appears necessary for TSST-1 production. The reduction in TSS toxin production and the effect of the composition on the wearer""s vaginal flora can be measured as described in the Test Methods (Example 4) section of this specification.
In a particularly preferred embodiment, the combination of the oxygen inhibiting agent and surface active agent causes at least about a 50% reduction in toxin production as measured by reporter gene fusion in vitro. More preferably, the combination of the oxygen inhibiting agent and surface active agent causes a reduction in toxin production in an in vitro laboratory test in the following amounts in ascending order of preference, at least about: 75%, 90%, and 99%. Still more preferably, it is desired for the combination of the oxygen inhibiting agent and the surface active agent to cause reduction in toxin production in the above amounts when the tampon is worn.
The oxygen inhibiting agent and the surface active agent can be applied in any suitable concentration (that is, an effective amount) which results in a reduction in TSS toxin production, but which does not negatively affect the wearer""s normal vaginal flora.
The invention will be illustrated by the following Examples, but the invention is not limited thereto and is fully applicable to the full disclosure.